陕西省药品监督管理局关于对陕西步长制药有限公司等药品生产企业药品GMP符合性检查结果的通告 根据《中华人民共和国药品管理法》《药品生产监督管理办法》《药品检查管理办法（试行）》《药品生产质量管理规范符合性检查工作程序》等有关规定 及要求，我局对陕西步长制药有限公司等3家药品生产企业进行药品GMP符合性检查和审核，经现场检查并综合评定，现将检查结果通告如下： | 企业名称 | 检查地址 | 检查范围及相关 | 检查时间 | | 检查结 | | --- | --- | --- | --- | --- | --- | | | | 车间、生产线 | | | 论 | | 陕西步长制药有限公 | 陕西省咸阳市秦都区步长路16 | 片剂（双氯胶囊车间片剂生产线）（磷酸西格列汀片 | 2025年9月16日-2025年9月19 | | 符合要 | | 司 | 号 | （100mg）） | 日 | | 求 | | | | 片剂，硬胶囊剂，颗粒剂（制剂车间片剂硬胶囊剂颗粒剂生产线） | | 2025年10月13 | 符合 | | 西安博爱制药 有限责任公司 | 陕西省华阴市华山镇 | 原料药(尼莫地平、尼群地平)（原料药车间原料药 ...

Group 1: Company Overview and Performance - The company achieved a revenue of 442 million CNY in the first half of 2025, an increase of 5.76% compared to the same period last year [4] - The net profit attributable to shareholders reached 53.95 million CNY, up 14.27% year-on-year [4] - The growth in revenue was driven by a 29.45% increase in revenue from chemical generic drugs and a 3.52% increase in key traditional Chinese medicine (TCM) products [4] Group 2: Research and Development - The company’s subsidiary, Huason Yingnuo, has seven innovative drug projects in clinical stages, covering various cancers and autoimmune diseases [3] - The innovative drug ORIC-1940 is currently undergoing Phase Ia/Ib clinical trials [3] - The company has successfully integrated with Chengdu Aorui Pharmaceutical, enhancing its R&D capabilities [3] Group 3: Product Development and Market Strategy - The company has five key TCM products that are essential for common and chronic diseases, with sales growth of 3.52% in the first half of 2025 [6][7] - The TCM product Pain Relief Granules saw sales increase by over 30% [7] - The company is focusing on building an academic system for key products and promoting them in clinical guidelines [7] Group 4: Sales Channels and Market Expansion - Approximately 70% of sales are generated from public hospitals, with efforts to expand into retail pharmacies and e-commerce platforms [8] - The company is actively working to increase its market share in outpatient clinics and other healthcare settings [8] Group 5: Special Medical Foods - The global market for special medical foods is approximately 3 billion USD, with China's market at around 7 billion CNY [9] - The company has four self-developed projects in this category and has received regulatory approval for its first special medical food product [11] - The production line for special medical foods is expected to gradually release capacity as new products are launched [11]

Core Viewpoint - Huason Pharmaceutical (002907.SZ) has received approval from the Chongqing Municipal Drug Administration for the re-registration of two pharmaceutical products: Glycyrrhizic Acid Ammonium and Sodium Ferulate Injection [1] Group 1: Product Approvals - The company has been granted a "Chemical Raw Material Drug Re-registration Approval Notice" for Glycyrrhizic Acid Ammonium, which is a raw material used for producing Glycyrrhizic Acid Ammonium Injection [1] - Additionally, the company received a "Drug Re-registration Approval Notice" for Sodium Ferulate Injection, which is used as an auxiliary treatment for ischemic cardiovascular and cerebrovascular diseases [1]

Core Viewpoint - Chongqing Huasen Pharmaceutical Co., Ltd. has received approval from the Chongqing Municipal Drug Administration for the re-registration of one chemical raw material (Dipotassium Glycyrrhizinate) and one drug (Sodium Ferulate Injection) [1] Group 1: Product Approvals - The re-registration approval includes a notification for the chemical raw material Dipotassium Glycyrrhizinate, which is used for the production of Glycyrrhizinate Injection [1] - The Sodium Ferulate Injection is indicated for the auxiliary treatment of ischemic cardiovascular and cerebrovascular diseases [1] Group 2: Impact on Operations - The re-registration approval will ensure the normal production and sales of the related drugs [1] - The company will strictly control product quality [1] - However, there is no significant short-term impact on the company's operating performance [1]

Core Viewpoint - Huason Pharmaceutical (002907.SZ) has received approval from the Chongqing Municipal Drug Administration for the re-registration of two pharmaceutical products: Glycyrrhizic Acid Dipotassium Salt and Sodium Ferulate Injection [1] Group 1: Product Approvals - The company has been granted a re-registration approval notice for Glycyrrhizic Acid Dipotassium Salt, which is a raw material used for producing Glycyrrhizic Acid Dipotassium Salt Injection [1] - The Sodium Ferulate Injection, which is used as an auxiliary treatment for ischemic cardiovascular and cerebrovascular diseases, has also received re-registration approval [1]